The FDA published a response to an article published in MedPage Today claiming that the agency did not require the sponsor of Narcan nasal spray, which contains naloxone as its active ingredient, to conduct clinical studies in a “real world” setting before approving the product. The criticism stems from the fact that naloxone can create intense withdrawal symptoms in opioid overdoses in which the patient is dependent. The nasal Narcan formulation – which is a new, on-label nasal naloxone as opposed to the atomizer kits sometimes used to adapt injectable naloxone – is a far higher dose than the injectable version. This could potentially increase the risk of withdrawal symptoms.

Sharon Hertz, Director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA’s Center for Drug Evaluation and Research, explains in part: “The article suggests that other forms of naloxone, such as injectables, may help to minimize the risk of withdrawal symptoms because they may be administered in a lower dose and over a longer time period. Though appropriate for medical settings where patients’ breathing and blood pressure can be supported, the incremental administration of smaller doses of naloxone to minimize withdrawal symptoms takes more time and medical expertise than may be available in an emergency.”

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